Regulatory Strategy Director — Global Impact (Hybrid)

Regulatory Jobs; Boston (MA); Hybrid; USD 232,000 - 348,000; Full time

Benefits offered by this job

Hybrid work arrangement

Competitive compensation and equity

Job summary

Vertex is seeking a Regulatory Strategy Senior Director to lead the development and implementation of advanced global regulatory strategies for multiple development programs, including emerging diseases and marketed products. This hybrid role involves 3 days/week onsite in Boston or Washington, D.C., collaborating with cross-functional teams to shape regulatory paths and liaise with health authorities.

The successful candidate will possess a strong business mindset, extensive regulatory

Qualifications

• Business-minded leader, capable of strategic thinking and proposing innovative regulatory solutions.
• Excellent communication skills to influence cross-functional teams and leadership.
• Regulatory leadership on cross-functional teams in a matrix environment.
• Technical expertise in regulatory affairs including global/regional/local frameworks and product development requirements.
• Advanced proficiency in analyzing data, safety reporting, labeling, and development activities.
• Experience in guiding development teams with regulatory pathway recommendations and health authority interactions.
• Ability to articulate strategic vision and improve internal regulatory policies and initiatives.
• Leadership and mentoring within regulatory teams with potential HR responsibilities.

Responsibilities

• Lead development of regulatory strategy for complex development projects from first-in-human to post-approval.
• Represent GRA on core development teams and align regulatory input with clinical and commercial strategy.
• Provide advanced regulatory solutions and guidance to cross-functional teams; communicate with senior management.

Skills

Strategic thinking

Regulatory leadership

Cross-functional collaboration

Communication skills

Matrix environment

Regulatory frameworks

Data analysis

Education

Bachelor's degree in Biology, Chemistry, or related discipline

Job description

Vertex is seeking a Regulatory Strategy Senior Director to lead the development and implementation of advanced global regulatory strategies for multiple development programs, including emerging diseases and marketed products. This hybrid role involves 3 days/week onsite in Boston or Washington, D.C., collaborating with cross-functional teams to shape regulatory paths and liaise with health authorities.

The successful candidate will possess a strong business mindset, extensive regulatory